Health TrialsbyHealthPanel

Bone Outcomes, Obesity, Sunlight, and Trauma in Children

ConditionsPediatric FracturesHypovitaminosis DObesity and Overweight
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-15
SponsorParacelsus Medical University

About this trial

Prospective case-control study of children (3-15 years) after low-energy trauma. We compare serum bone metabolic markers (25OHD, PTH, ALP, calcium, phosphate), BMI/percentile, and dietary calcium intake between fracture and non-fracture presentations. Blood is collected within 7 days (non-fasting; samples on ice for PTH). Primary aim: association of ALP and calcium with fracture status; secondary aims: vitamin D status, BMI percentile, and a composite Bone Risk Score (≥3). Analyses: group comparisons, logistic regression, ROC.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

3-15 years;

low-energy trauma;

cases = radiographic fracture; controls = no fracture.

Disqualifiers

chronic renal/liver disease;

primary hypo-/hyperparathyroidism;

hypophosphatemic rickets;

neuromuscular disorders;

Trial population

Children and adolescents aged 3 to 15 years presenting to emergency services after low-energy trauma. Eligible participants include those with radiologically confirmed fractures (case group) and those with comparable trauma without fractures (control group). All participants are otherwise healthy and free from chronic conditions or treatments that may influence bone metabolism.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Fracture group
Group B: Control group

Trial outcomes

Primary outcomes

1

Serum 25-hydroxyvitamin D (nmol/L)

Blood level of vit D

Time frame
within 7 days
2

BMI

Relation between BMI and Fracture

Time frame
at baseline

Secondary outcomes

1

Calcium, Phosphate, alkaline phosphatase

Serum level of bone metabolism markers

Time frame
within 7 days from trauma
2

bone risk score

proportion with score ≥3

Time frame
at baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Paracelsus Medical University

Lead sponsor

Source ClinicalTrials.gov
Apply now